Ligence Heart— 510(k) K253535

Substantially Equivalent

Ligence Uab

FDA 510(k) clearance K253535 for Ligence Heart, Substantially Equivalent on 2026-02-27. Applicant: Ligence Uab. Device class: 2.

Clearance details

Applicant: Ligence Uab
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-11-13
Decision date: 2026-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaunas, LT

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Ligence Uab

K252105 — Ligence Heart2025-09-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.